Distracted Driving App Study for Teens and Parents/Caregivers

NCT04177524 | Completed

• 1 other identifier: 19-016717
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application

Conditions

Distracted Driving

Outcome Measures

Primary Outcomes (1)

• Change in frequency of smartphone use while driving

  Frequency of smartphone use is recorded by the LifeSaver app among the three app modes. Within-driver smartphone use over the 8-week study period is compared as the app modes change.

  Week 2, 4, 6, and post-intervention at Week 8

Secondary Outcomes (3)

• Change in frequency of self-reported smartphone use while driving

  Weeks 2, 4, 6, and Post-Intervention at Week 8

• Participant acceptability of the smartphone App: survey

  Post-Intervention at Week 8

• Participant usability of the smartphone app: survey

  Post-Intervention at Week 8

Study Arms (3)

Arm 1

EXPERIMENTAL

Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).

Device: Manual Mode; Device: Auto-Detect Mode

Arm 2

EXPERIMENTAL

Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.

Device: Manual Mode; Device: Auto-Detect Mode

Arm 3

EXPERIMENTAL

Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.

Device: Background Mode; Device: Auto-Detect Mode

Interventions

Background Mode DEVICE

The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.

Also known as: Mode 1

Arm 3

Manual Mode DEVICE

In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.

Also known as: Mode 2

Arm 1; Arm 2

Auto-Detect Mode DEVICE

In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Also known as: Mode 3

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Licensed teen drivers 16 years to 18 years and one parent/caregiver
• Teen and parent/caregiver are both Android smartphone users
• Teen and parent/caregiver both drive a minimum of 2 days per week

You may not qualify if:

• Non-fluency in written or spoken English

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Minnesota HealthSolutions: collaborator

Study Sites (1)

Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Philadelphia, Pennsylvania, 19146, United States

Location

Study Officials

• Allison Curry, PhD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Sara Seifert, MPH

  Minnesota HealthSolutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are aware of the differences between the app modes, and that the order in which they test out the different app modes is randomly assigned to them. The study team is not blinded to which study arm participants are assigned to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will utilize a crossover design with randomized assignment to three study arms to allow for comparison of app modes within drivers as each driver will act as their own control. The three app modes are: Background Mode (app runs in background and participants do not lock/unlock the phone), Manual Mode (participants manually unlock the phone), and Auto-Detect Mode (participants are automatically locked out of their phone if their phone camera detects them to be a driver or are automatically allowed to use their phone if the camera detects them to be a passenger).

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: January 23, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.
• Access Criteria: IRB approval, data use agreement

Locations

US (1)